Cleared Traditional

K000920 - REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

K000920 is an FDA 510(k) clearance for REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI..., manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K000920 · Corgenix, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
35d
Days
Class 2
Risk

K000920 is an FDA 510(k) clearance for the REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on April 26, 2000 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000920

510(k) Number K000920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date April 26, 2000
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 105d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MID System, Test, Anticardiolipin Immunological

All 93
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K000920.
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069 · Quest Intl., Inc. · Nov 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981 · Axis-Shield , Ltd. · Aug 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574 · Axis-Shield · Jun 2000
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085 · Cogent Diagnotics , Ltd. · Feb 2000
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · Cogent Diagnotics , Ltd. · Sep 1999
K000920 · REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
Download PDF FDA Summary Corgenix, Inc.